Guaifenesin Oral Solution Usp

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Sodium Citrate Sodium Sorbitol Solution Sucralose Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-10

Medication Information

Purpose

Expectorant

Description

Guaifenesin 100 mg

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Directions

do not take more than 6 doses in any 24-hour period

Age	Dose
Adults and Children 12 years and over	2-4 Teaspoonfuls every 4 hours
Children 6 years to under 12 years	1-2 Teaspoonfuls every 4 hours
Children 2 years to under 6 years	1/2-1 Teaspoonful every 4 hours
Under 2 years	Ask a doctor

Drug Facts (continued)

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:

Oncor Pharmaceuticals

8815 Center Park Dr. Suite 430

Columbia, Maryland 21045

Other Information

store at 20°-25°C (68°-77°F)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
sodium content 3 mg/5 mL

Inactive Ingredients

Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

Principal Display Panel

NDC 83720-503-16

ONCOR PHARMACEUTICALS

Guaifenesin

Oral Solution USP

100 mg/5 mL

Expectorant

Relieves Chest Congestion

Sugar Free • Alcohol Free

Cherry Flavor

16 fl. oz. - 473 mL

Stop Use and Ask A Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Active Ingredient (in Each 5 Ml Teaspoonful)

Guaifenesin 100 mg

Structured Label Content

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

Purpose

Expectorant

Directions

do not take more than 6 doses in any 24-hour period

Age	Dose
Adults and Children 12 years and over	2-4 Teaspoonfuls every 4 hours
Children 6 years to under 12 years	1-2 Teaspoonfuls every 4 hours
Children 2 years to under 6 years	1/2-1 Teaspoonful every 4 hours
Under 2 years	Ask a doctor

Drug Facts (continued)

Questions?

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.

Manufactured for:

Oncor Pharmaceuticals

8815 Center Park Dr. Suite 430

Columbia, Maryland 21045

Other Information (Other information)

store at 20°-25°C (68°-77°F)
Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.
sodium content 3 mg/5 mL

Inactive Ingredients (Inactive ingredients)

Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 83720-503-16

ONCOR PHARMACEUTICALS

Guaifenesin

Oral Solution USP

100 mg/5 mL

Expectorant

Relieves Chest Congestion

Sugar Free • Alcohol Free

Cherry Flavor

16 fl. oz. - 473 mL

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Active Ingredient (in Each 5 Ml Teaspoonful) (Active ingredient (in each 5 mL teaspoonful))

Guaifenesin 100 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.", "Purpose": "Expectorant", "Directions": "do not take more than 6 doses in any 24-hour period Age Dose Adults and Children 12 years and over 2-4 Teaspoonfuls every 4 hours Children 6 years to under 12 years 1-2 Teaspoonfuls every 4 hours Children 2 years to under 6 years 1/2-1 Teaspoonful every 4 hours Under 2 years Ask a doctor Drug Facts (continued)", "Questions?": "You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088. Manufactured for: Oncor Pharmaceuticals 8815 Center Park Dr. Suite 430 Columbia, Maryland 21045", "Other information": "store at 20°-25°C (68°-77°F) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. sodium content 3 mg/5 mL", "Inactive ingredients": "Citric acid, Cherry flavor, FD&C red No. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium, sorbitol solution, sucralose.", "PRINCIPAL DISPLAY PANEL": "NDC 83720-503-16 ONCOR PHARMACEUTICALS Guaifenesin Oral Solution USP 100 mg/5 mL Expectorant Relieves Chest Congestion Sugar Free • Alcohol Free Cherry Flavor 16 fl. oz. - 473 mL", "Stop use and ask a doctor if": "cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "Active ingredient (in each 5 mL teaspoonful)": "Guaifenesin 100 mg"}

Guaifenesin Oral Solution Usp

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information